Memorandum submitted by Professor David
J Kerr, Professor of Clinical Oncology, CRC Institute for Cancer
Studies, University of Birmingham

1. INTRODUCTION

1.1 Relevance of submission to the Inquiry

1. David Kerr has been the Professor of Clinical
Oncology in Birmingham since March 1992 and has been instrumental
in establishing the new Institute of Cancer Studies at the University
of Birmingham, which has a research staff of around two hundred
clinical and basic scientists.

2. He has won several international prizes,
has published more than 150 articles in peer-reviewed journals
and has a competitive grant income of several million pounds.

3. He is Director of the CRC Clinical Trials
Unit, one of the countries leading centres for the design, conduct
and analysis of cancer trials. The main areas of research interest
are in early drug development trials, multi-centre PIII trials
in gastro-intestinal cancer and gene/immunotherapy therapy.

4. He chairs an Advisory Group that will
report to the Department of Health in June 2000, on the optimal
future strategic direction for NHS R&D investment in cancer.

1.2 The Infrastructure for cancer treatment
and importance of research to the NHS

5. The UK tends to fare rather badly in
international comparisons of cancer survival rates. Reviews have
demonstrated wide variations in survival outcomes achieved by
individual clinicians, hospitals and local and regional health
authorities, and suggest a benefit of specialisation and specialist
teams.

6. The available data suggests potential
problems in variable practice and service delivery which thus
prompted the Department of Health to publish a policy framework
for commissioning cancer services. The Calman-Hine report (1994)
proposed a broad framework which defined a network of cancer centres
and units underpinned by continuing community care. This paper
was not prescriptive, but was, rather, open to adaptation to local
circumstance.

7. The drive to deliver high quality care,
widely and equitably, has led to a renewed commitment to "evidence
based" medicine within the NHS. It is widely recognised that
adopting state-of-the-art comparative treatment protocols is necessary
to reliably inform the management of future patients and that
participation provides patients with access to the best current
care options.

1.3 Current status of the UK's Cancer Research
Portfolio

8. The UK Government provides funding for
cancer research through the Research Councils and Department of
Health and there is also a strong history of voluntary sector
funding.

9. Oncology has a long-standing, multidisciplinary
research culture and the benefit of strong and wide-ranging investment
in basic science and clinical research. The United Kingdom Co-ordinating
Committee for Cancer Research (UKCCCR) reports that there is a
significant investment in basic and clinical cancer research from
the public and charitable sectors.

10. Research funding in the UK is increasingly
well co-ordinated, independently peer reviewed and directed towards
addressing priority areas. The recent creation of the Cancer Funders
Forum will further strengthen the position.

11. The current funding umbrella does not
adequately cover the extra service and research support resources
needed to treat patients in the context of clinical trials. The
NHS clinical research effort is most vulnerable at the clinical
interface.

1.4 Development of the cancer clinical trials
portfolio

12. There are several different levels of
UK "think tanks" that function to identify and prioritise
the major questions for each of the different cancer speciality
areas, and to develop and put forward the best practicable trial
designs to address them. The process is geared toward filtering
out the unworkable and the less important topics.

 The UKCCCR organises a series of
site specific groups.

 There are a number of strong UK collaborative
clinical groups that provide channels for new ideas, leadership,
communication, feasibility testing and recruitment to trials.

 Membership of collaborative groups
formed to conduct a specific trial or series of trials is generally
decided by individual clinicians' willingness to participate and
is usually managed by the CTO(s) responsible.

1.5 Interactions and partnership with the
Pharmaceutical and Biotechnology Industry

13. The Pharmaceutical and Biotechnology
Industry have active research programmes, ranging from early drug
development trials through large randomised, international comparative
studies into marketing studies. Participation in commercially
sponsored studies is an important source of access to new compounds
and external support for many oncology centres.

14. There is no doubt that access to a continued
supply of new potential anti-cancer treatments via participation
in early drug development trials is seen by patients and oncologists
alike as one of the hall-marks of cutting edge cancer research
within the NHS.

15. The NHS needs to provide a research
environment capable of responding to industry needs for rapid
turnaround and high quality data at reasonable cost in order to
secure access to new compounds and large scale investment funding.

16. There are a number of small to medium
sized, innovative, high quality research based biotechnology companies
who face prohibitive costs in undertaking clinical trials for
licencing purposes. There may well be opportunities for the formation
of innovative partnerships that would potentially improve the
viability and range of this research.

1.6 Early drug development and translational
research

17. The public sector needs to support an
independent, academic led, drug development trials portfolio.

18. The key to providing optimal cancer
care for the NHS is to support the translation of our own basic
science platform into trials of clinical and academic relevance.

19. In part, this is to retain our international
competitiveness in basic research into the causes and mechanisms
of cancer (against other European and US academic centres and
multi national pharmaceutical companies).

20. There is genuine patient demand and
need for access to novel, unlicensed agents in the context of
rigorously conducted clinical trials. Although the chance of therapeutic
benefit is small, most report that participation offers psychological
and altruistic benefits.

21. These studies are necessarily intensive
and demanding on clinical time, extra NHS services and the availability
of multidisciplinary teams which include strong academic input.

22. It follows that this portfolio is best
managed from within a few, geographically distributed "comprehensive"
cancer centres that typically are associated with Medical Schools.

24. This is the area in which there is most
cooperation between the cancer research funding bodies. The UK
has followed a worldwide trend in having evolved a number of dedicated
centres that specialise in the design, management and analysis
of clinical trials. There are a limited number of Clinical Trials
Offices (CTO) that are subject to a regular process of peer review,
and with the confirmed capacity and expertise to develop, coordinate
and analyse UK and International multicentre trials.

25. There is also a demand for increased
bio-statistical, IT and trial management expertise to support
local research needs and projects. There are a number of small
trials offices (funded predominantly by CRC) in large, metropolitan
cancer centres. More small trials units, with statistical and
IT support, are being created by Trusts.

1.8 Barriers to clinical research: recruitment
and data quality

26. The main factors limiting the conduct
of cancer research within the NHS, and the delivery of timely
medical evidence are sub-optimal recruitment and patchy quality
of data for the clinical trials that are undertaken.

27. It is clear that lack of dedicated time
and resources for research are major barriers to the translation
of clinical interest into recruitment and the delivery of high
quality, timely data (Prescott et al, 1999). Fallowfield's survey
of 357 UK cancer specialists published in 1997 reported that 99
per cent took part in trials, but only 25 per cent believed they
were regularly entering £50 per cent of their eligible patients.
This data indicates that the UK's research active community has
considerable scope to increase recruitment given the necessary
resources.

28. Clinical interest and support may be
rallied by providing them with clinical support staff, easier
call on any extra NHS service and treatment resources required
by protocols, and improved access to the expertise of local and
national Clinical Trial Offices (CTOs)

29. Hence the recent report from the NHS
Cancer Working Group (Report on Strategic priorities in Cancer
Research and Development, 1999) identified a primary strategic
need to focus on providing support for the front line clinical
researchers.

1.9 Overcoming barriers to the dissemination
and adoption of clinical trial evidence

30. It is widely acknowledged that there
is a gap between making new evidence available to the NHS and
its incorporation into best clinical practice

31. The NHS Cancer Working Group report
(1999) noted that there is no system for monitoring the delivery
of care to see if effective therapies are being implemented and
ineffective ones discontinued.

32. There is evidence to suggest that participation
in trials facilitates the adoption of evidence based medicine.
This is probably due in part, to the break down of any clinical
barriers toward understanding and acceptance of the findings.
Organisational and infrastructural adaptation during the trial
may help cushion the impact of consequent changes in practice.

33. Thus a very important and effective
route to get research findings rapidly into practice is by maintaining
a cohesive UK-based research portfolio, thus training future generations
of clinicians in the benefits of evidence based practice.

1.10 Summary

34. This country has an outstanding record
of scientific innovation in cancer research, that rests on mutual
support between the NHS, universities and bodies funding high
quality R&D.

35. The cancer research community has effective
networks in place for the identification, prioritisation and conduct
of clinical research. The recent establishment of the Cancer Funders
Forum will strengthen this position.

37. The National Health Service has the
potential to provide an internationally recognised broad platform
for the conduct clinical research and adoption of evidence based
medicine.

2. THE WAY
FORWARD

38. The best way forward is a co-ordinated
approach that will strengthen the UK Cancer research identity
via integration to optimise the use of the existing research resources
and joint investment in a centrally co-ordinated clinical network
or "co-operative group".

39. There is no added value, or need, to
establish a monolithic UK National Cancer Institute.

40. There is a need to develop closer working
links between the "think tanks", research sponsors,
clinical trial organisers and the clinical interface.

41. The priority should be to establish
a new, co-ordinated network of clinical centres and provide the
necessary research workforce and protected resources necessary
to conduct trials as a mainstream activity in the NHS.

42. Such a network would map naturally onto
the network currently being implemented for delivery of cancer
services in the NHS under the Calman-Hine plan.

43. Major investment is needed to embed
an infrastructure for research in NHS clinical centres and to
encourage and support clinicians who wish to adopt clinical trials
as a routine part of patient care.

44. In order to remove the major organisational
barriers to cancer R&D in the NHS, reorganisation should address
the provision of a trained workforce where most needed in trial-oriented
clinics and improved access to support for meeting the major rate
limiting excess service and treatment costs associated with individual
protocols.

45. Research active clinical centres should
be supported in the development of a structured, stable local
research organisation capable of undertaking a rolling programme
of trials and of interfacing effectively with research bodies.

46. At present NHS clinical centres control
access to patients and data, but participation is a voluntary
activity, largely without tangible rewards or accountability.
Future investment in R&D infrastructure should be quality
managed, with participating NHS clinical centres sharing more
fully the responsibility for the success of trials in terms of
meeting recruitment targets and adherence to protocol.

47. The public sector has a need to establish
recognised mechanisms to link funding to performance and encourage
the development of accredited clinical centres working to a recognised
standard of research excellence.

48. These mechanisms should aim to facilitate
the passage of new treatments from the lab to the clinic and create
co-ordinating centres for Phase I, II and III clinical trials.
The infrastructure needed to participate in cutting edge research
and associated benefits (high quality cancer care, rapid take
up of results) should be geographically distributed so as to be
within reach of the majority of interested clinicians and patients.

49. The development of a highly trained
and responsive research support network would provide an attractive
platform for new research investment and partnership with industry.

50. There is the opportunity to bring together
the key stake holders in cancer research under a single umbrella
in order to create a "distributed" National Cancer Institute,
that will retain existing funding sources, flexibility and ability
to innovate and build on the nation's intellectual and infrastructural
strengths. The "missing link" is a co-ordinated research
infrastructure within the NHS. Addressing this key organisational
development need offers great added value in terms of improving
the efficiency and throughput of the entire research and development
cycle in the UK.